Severity
Moderate
ModerateClass IIOngoing
FDA Devices recall · Reported July 19, 2023
GE Healthcare Vivid S60N, ultrasound device
GE HealthCare has become aware that certain Vivid ultrasound systems cannot boot up in a timely fashion. If this occurs, it can delay availability of the device in time-critical e…
Ge Vingmed Ultrasound As recalled GE Healthcare Vivid S60N, ultrasound device - a moderate-severity action.
GE Healthcare Vivid S60N, ultrasound device was recalled by Ge Vingmed Ultrasound As in July 19, 2023. Reason: GE HealthCare has become aware that certain Vivid ultrasound systems cannot boot up in a timely fashion. If t…. Check the official notice for the remedy. Verify recall #Z-2126-2023 with the FDA Devices before acting.
The recall
Ge Vingmed Ultrasound As issued this moderate-severity FDA Devices recall-GE HealthCare has become aware that certain Vivid ultrasound systems cannot boot up in a timely fashion. If t….
- Moderate
- severity level
- Class II
- classification
- July 19, 2023
- reported
Sourced from official FDA Devices enforcement records. Verify recall #Z-2126-2023 with the agency before acting. Full product description, hazard, remedy, and related recalls are below.
Recall Insight
This FDA Devices action (record #Z-2126-2023) was formally reported on July 19, 2023, with the manufacturer initiating the action on May 30, 2023. It is classified under Moderate severity (Class II), with a current status of Ongoing. Ge Vingmed Ultrasound As is listed as the recalling firm, operating out of Horten, N/A. Federal records list the affected scope as N/A.
The documented reason for this recall is: GE HealthCare has become aware that certain Vivid ultrasound systems cannot boot up in a timely fashion. If this occurs, it can delay availability of the device in time-critical emergency situations. Distribution data in the federal record shows the product reached: Worldwide distribution.. Distribution scope directly affects the consumer exposure window and determines whether a recall remains regional or escalates into a nationwide advisory.
Within the same product category the archive holds 6 closely related recalls, 3 from FDA Devices - clustering in a narrow category often points to a systemic quality-control or supplier issue rather than a one-off defect. Always verify the recall number against the official agency record before acting.
Medical Devices recalls over time
Where this recall sits in its category - 40,322 medical devices recalls on record
Of 101,704 recalls in the database, 24,878 are high severity, 72,426 moderate, and 4,400 low. This recall is classified moderate severity.
Counts reflect market size and reporting activity, not inherent danger, we do not rank products by risk from raw recall volume.
Affected scope
N/A
Related Recalls
6
3 from same agency
Product description
GE Healthcare Vivid S60N, ultrasound device
Reason for recall
GE HealthCare has become aware that certain Vivid ultrasound systems cannot boot up in a timely fashion. If this occurs, it can delay availability of the device in time-critical emergency situations.
Recall Profile
| Attribute | Value |
|---|---|
| Agency | U.S. Food and Drug Administration |
| Severity class | Moderate (Class II) |
| Status | Ongoing |
| Recall number | Z-2126-2023 |
| Date reported | July 19, 2023 |
| Date initiated | May 30, 2023 |
| Recalling firm | Ge Vingmed Ultrasound As |
| Firm location | Horten, N/A |
| Affected scope | N/A |
| Distribution | Worldwide distribution. |
Profile values are sourced directly from the official FDA Devices enforcement record. Source: U.S. Food and Drug Administration.
What to do with this recall
Match your product against the recall record, then act on the agency remedy.
- Check the recall number (Z-2126-2023) and product description against the item you own. Search the archive
- Confirm the current status with FDA Devices before acting, recall details can be updated.
- Follow the documented remedy (refund, replacement, repair, or disposal) rather than general advice. What to do next
This page summarizes the official FDA Devices record for research and awareness; it is not legal, medical, or safety advice. Verify with the issuing agency before acting.
Frequently Asked Questions
What product was recalled? ▼
GE Healthcare Vivid S60N, ultrasound device. Recalled by Ge Vingmed Ultrasound As. Units affected: N/A.
Why was this product recalled? ▼
GE HealthCare has become aware that certain Vivid ultrasound systems cannot boot up in a timely fashion. If this occurs, it can delay availability of the device in time-critical emergency situations.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on July 19, 2023. Severity: Moderate. Recall number: Z-2126-2023.
Where was the recalled product distributed? ▼
Distribution: Worldwide distribution..
How do I check if my product is affected by a recall? ▼
Check the product description and recall number (Z-2126-2023) against your product. Visit the official FDA Devices website for the most current information. You can also use our Recall Checker tool to search by product name or brand.
Should I stop using a recalled medication or medical device? ▼
Do not stop using a recalled medication or device without consulting your healthcare provider first, as abruptly discontinuing treatment could pose its own health risks. Your doctor can advise on alternatives or whether the recall applies to your specific product lot. Check the recall number and lot information against your product packaging.
Nearby Recalls in This Category
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Every figure on PlainRecalls is rendered directly from official FDA, CPSC and NHTSA recall records, no number is typed in by an editor. This recall: FDA Devices, reported July 19, 2023. Severity classes follow each agency's own taxonomy (FDA Class I/II/III; CPSC and NHTSA by hazard type), and related-recall context is computed across the full archive. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error. Data current as of July 2026.